CEFUROXIME 250 Milligram Tablets
Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Karakteristik produk
(SPC)
25-04-2024
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Bahan aktif:
CEFUROXIME AXETIL
Tersedia dari:
Sandoz Ltd
INN (Nama Internasional):
CEFUROXIME AXETIL
Dosis:
250 Milligram
Bentuk farmasi:
Tablets
Status otorisasi:
Withdrawn
Tanggal Otorisasi:
2009-06-02
Karakteristik produk
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0372/009/002
Case No: 2052305
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANDOZ LTD
37 WOOLMER WAY, BORDON, HANTS GU35 9QE, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CEFUROXIME 250MG TABLETS
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 25/08/2008 until 07/12/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/09/2008_
_CRN 2052305_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime 250mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300.72 mg cefuroxime axetil which is equivalent to 250 mg cefuroxime per tablet.
For excipients: see 6.1.
3 PHARMACEUTICAL FORM
Coated tablets.
White to slightly yellowish, biconvex, oblong tablets, scored on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime axetil is indicated for the treatment of mild to moderately severe infections caused by micro-organisms
susceptible to cefuroxime, such as:
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
- acute bronchitis, ac
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